San Francisco-based Bunkerhill Health has received clearance from the U.S. Food and Drug Administration (FDA) for its AI algorithm for detecting and quantifying mitral annular calcification (MAC).
Called Bunkerhill MAC, the algorithm was designed to detect mitral annular calcification -- a chronic condition in which calcium deposits build up in the mitral valve ring -- on nongated chest CT scans performed for noncardiac indications. Often discovered incidentally, studies have linked MAC to increased cardiovascular risk, including higher rates of mortality and complications in structural heart procedures, Bunkerhill said.
The algorithm was developed and tested on data from a multi-institutional research consortium of more than 25 academic medical centers, the company added.
